Infant Medicine Recalled for Acetaminophen Instability

KinderFarms is voluntarily recalling all lots of the over-the-counter (OTC) medication KinderMed Infants’ Pain & Fever due to an acetaminophen instability, according to a November 13, 2023, company announcement.

“The two products were manufactured and packaged for KinderFarms by a major, US-based OTC pharmaceutical manufacturer with over 30 years of experience,” the announcement stated. “Ongoing testing of sample batches indicated some product lots were no longer in specification and may pose a health risk. Out of an abundance of caution, KinderFarms has made the decision to voluntarily recall all KinderMed Pain & Fever products.”

The recall, which was included in the December 13, 2023, US Food and Drug Administration (FDA) Enforcement Report, affects 376,370 bottles of KinderMed Infants’ Pain & Fever (acetaminophen 160 mg per 5 mL), oral suspension, organic cherry flavor, 2 fluid ounces/59 mL (NDC 82673-096-02, UPC 850001805698). The affected lots are CJ70902 (Exp. 7/24); CJ76275 and WJ81412 (Exp. 8/24); WK02194, WK02196, WK04141, WK02873, and WK05542 (Exp. 10/24); WK02874 and WK04794 (Exp. 1/25); and WK04793 and WK06535 (Exp. 3/25).

The products were distributed throughout the United States by KinderFarms, Redondo Beach, California.

KinderFarms initiated the recall November 13, 2023. On December 6, 2023, the FDA designated it Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

“As a result of the potential health risk with acetaminophen being outside of specification, the product may cause acute adverse health effects, including abdominal pain, nausea, vomiting or jaundice at higher doses,” KinderFarms stated. KinderMed Infants’ Pain & Fever is used to temporarily reduce fever and relieve minor aches and pains in children ages 2 to 3 years.